Industry News and Products

Spectranetics Announces FDA Clearance of VisiSheath™ Dilator Sheath, New Lead Management Device

Enhanced Visibility and Performance Features Help Physicians Dilate Scar Tissue Surrounding Problematic Cardiac Leads Requiring Removal Spectranetics Corporation announced it has received Food and Drug Administration (FDA) 510(k) clearance for its new VisiSheath™ Dilator Sheath device. This expands the market for VisiSheath, which recently also received CE Mark approval in Europe. The VisiSheath Dilator Sheath may be used alone as an independent sheath for dilating tissue surrounding cardiac leads, or as an enhanced outer support sheath in conjunction with compatible inner sheaths such as Spectranetics’ Laser Sheath (SLS® II), a laser-based system for removing problematic pacing and defibrillator leads. The VisiSheath Dilator Sheath is an enhanced tool to help physicians free cardiac leads from binding scar tissue that makes removal challenging by dilating the affected area. The VisiSheath device employs unique gold-coated steel marker bands to provide physicians with more than 200 percent better fluoroscopic visibility of the device tip than standard Teflon® or polypropylene sheaths. An advanced multi-layer construction and robust tip design deliver high performance for navigating over leads and dilating tissue. The first human use of the VisiSheath device took place in Sweden in a laser-assisted lead removal procedure performed by Dr. Charles Kennergren, Associate Professor of Cardiothoracic Surgery at the Sahlgrenska University Hospital in Gothenburg. Dr. Kennegren commented, “VisiSheath’s fluoroscopic visibility is excellent. I found the device especially useful in supporting the laser sheath through the subclavian vein, reducing friction from the clavicle and increasing the tactile feel when maneuvering the laser sheath. For physicians that do not use the laser sheath, I believe this device will provide a nice, high-performance alternative to existing simple plastic sheaths.” Following initial introduction of VisiSheath into the U.S. market, Dr. Bruce Wilkoff, Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic, utilized it as an outer sheath for the SLS II laser sheath in a laser-assisted lead removal procedure at Cleveland Clinic. Dr. Wilkoff stated, “It is valuable for extraction sheaths to be visible on fluoroscopy and to provide for torque control. These characteristics favor safe advancement of extraction sheaths through fibrotic tissues.” Both Dr. Kennergren and Dr. Wilkoff are members of the physician medical advisory board for Spectranetics. More than two million Americans rely on a pacemaker or defibrillator to regulate their heartbeat. These devices rely on cardiac leads to deliver electrical impulses to the heart and detect the heart’s electrical activity. Physicians are recommended to remove cardiac leads when complications occur, such as infection or malfunction. Spectranetics’ excimer laser technology offers a safe means to remove cardiac leads by using pulsed bursts of ultraviolet (UV) light energy to break down scar tissue holding leads in place, thereby enabling effective removal. The newly FDA-cleared VisiSheath Dilator Sheath device will complement the laser-based system as an outer support sheath. Additionally, it will offer a non-laser option to mechanically dilate scar tissue for physicians who do not use laser assistance to manage all of their patients with lead complications. “As more patients receive pacemakers and defibrillators at a young age, there is a growing need to address complications associated with problematic leads,” said Emile Geisenheimer, Chairman, President and Chief Executive Officer at Spectranetics. “The VisiSheath Dilator Sheath represents an important advancement in the treatment of lead-related complications.” To provide options for different clinical scenarios and user preferences, the VisiSheath Dilator Sheath device is offered in nine sizes, comprised of combinations of three different diameters and three different lengths. ___________________

Sorin Group Announces the First Inclusion in the Clepsydra Clinical Study in the U.S.

The Clepsydra Study will Evaluate the Effectiveness of PhD™, a New Sensor-Based Function Designed to Monitor Patient Clinical Status Sorin Group announced the first inclusion of a patient in the Clepsydra clinical trial. The study will investigate the sensitivity to changes in heart failure status of PhD™, a unique diagnostic feature using the dual sensor technology of minute ventilation and accelerometer to monitor a patient’s breathing and activity levels every day. The algorithm aims to provide physicians with both trends and indicators in order to highlight sustained changes in overall health status that could relate to heart failure (HF) evolution. PhD™ is available in the Paradym™ family of implantable cardioverter defibrillators (ICD) in Europe and under clinical evaluation in implantable cardiac resynchronization therapy defibrillators (CRT-D) in Europe and the U.S. According to the American Heart Association (AHA) and the European Society of Cardiology (ESC) guidelines, heart failure currently affects about 5 million Americans and 15 million people in the 35 countries under the auspices of the ESC. Heart failure is the most common Medicare diagnosis-related group (hospital discharge diagnosis), and more Medicare dollars are spent for the diagnosis and treatment of HF than for any other diagnosis. In Europe, HF accounts for about 2% of national expenditures on health. As the severity of HF can fluctuate and drug therapies adjusted to improve the patient’s condition, it is important to monitor recognized indicators of disease progression to prevent the patient being hospitalized. PhD™ measures activity workload and ventilation at rest and exercise, which are two key measurements to indicate that a patient’s heart failure condition is progressing. The Clepsydra study will test the PhD™ algorithm that is designed to give advance notice of sustained deterioration. Advanced warning at follow-up could give physicians time to intervene in the patient’s treatment to avoid the costs and patient burden associated with hospitalization. The Clepsydra study will evaluate PhD™ in 550 patients to be enrolled in the U.S. and Europe. Patients will be closely monitored over a minimum of 13 months by hospital visits and by telephone checks. The first implant was performed by Andrew J. Kaplan, MD, cardiac electrophysiologist with CVAM, CardioVascular Associates of Mesa, at Mountain Vista Medical Center in Mesa, Arizona. Dr. Kaplan noted, “Tracking and managing heart failure progression in our patients is complex and time consuming. The Clepsydra study should help us better predict and intervene earlier in the heart failure process through evaluation of the data collected by the PhD™ sensor-based function. The implantation in our first patient was smooth and the device performed well.” “Our vision is to provide new and innovative tools to physicians and relieve the burden of heart failure for all stakeholders. Monitoring of the patient physiological status (PhD) is an important step to giving physicians an accurate guide to optimizing heart failure therapy and avoid costly hospitalizations,” said Stefano Di Lullo, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit. ____________________

Vascular Solutions Launches the PiggyBack™ Wire Converter

Vascular Solutions, Inc. announces the availability of the new PiggyBack™ wire converter, a completely unique device designed for peripheral interventional procedures when both a 0.014” guidewire and a 0.035” guidewire are required. The PiggyBack is a 0.035” outer diameter catheter that can be delivered over and locked onto any standard 0.014” guidewire to allow subsequent delivery of intravascular devices. The PiggyBack converts the 0.014” guidewire into a 0.035” delivery device, preserving the position of the 0.014” guidewire and eliminating the need to switch-out or exchange guidewires. It can either be delivered over a 0.014” guidewire that is already positioned in the vessel or preloaded onto a 0.014” guidewire before it is introduced into the body. The PiggyBack features a 0.035” outer diameter sliding lock, hydrophilic coating for smooth delivery, a radiopaque marker band embedded in the distal tip for visualizing location, and is available in 80cm, 120cm, and 145cm lengths. The PiggyBack is currently available for sale in the United States via Vascular Solutions’ direct sales force. Vascular Solutions, Inc. is a leading medical device company that delivers proprietary clinical solutions for diagnosing and treating vascular conditions. The company’s rapidly growing product line consists of innovative devices across established and emerging areas of coronary and peripheral vascular medicine. PiggyBack is a trademark of Vascular Solutions, Inc. __________________

Bioniche Pharma and Academic Pharmaceuticals, Inc. Announce the Introduction of Sotalol Hydrochloride Injection

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, and Academic Pharmaceuticals, Inc. (API), a research and development company specializing in cardiovascular products, announced that Sotalol Hydrochloride (HCl) Injection for intravenous use is now available. Sotalol Hydrochloride tablets are currently available under the brand name Betapace®. Bioniche Pharma and API entered into an agreement whereby API developed and secured the FDA approval of Sotalol HCl Injection and Bioniche Pharma maintains the exclusive rights to manufacture, market, and distribute the product in the United States. “Bioniche Pharma is very pleased to launch Sotalol HCl Injection,” said George Zorich, President, U.S. Operations for Bioniche Pharma. “We partnered with API due to their knowledge of anti-arrhythmic treatment options and patient needs. This product expands Bioniche Pharma’s growing portfolio of branded products.” Sotalol HCl Injection is currently available and Bioniche Pharma attended the November American Heart Association meeting in Orlando, Florida as part of their introduction of the product. Sotalol HCl Injection has a black box warning relating to life-threatening proarrhythmia. Please refer to the Bioniche Pharma website for the complete prescribing information, including the boxed warning. Bioniche Pharma is a global manufacturer of injectable pharmaceutical products serving a variety of niche markets, with expertise in injectable hyaluronic acid products for use in orthopedics, rheumatology, urology, and dermatology. An internal development pipeline and an aggressive acquisition strategy for products fuel the company’s growth. RoundTable Healthcare Partners, a private equity firm based in Lake Forest, Illinois, acquired Bioniche Pharma in February 2006. Academic Pharmaceuticals, Inc. is a Research and Development company specializing in cardiovascular products. The company specializes in developing anti-arrhythmic parenteral compounds and other cardiovascular drugs that are needed by practicing cardiologists or emergency room physicians. Many of the products in development are orphan drugs that serve specialized populations. The company’s expertise is in solubilization of insoluble compounds and designing expedited clinical development and regulatory review programs. Betapace® is a registered trademark of Bayer Schering Pharma. _________________

nContact Announces Initiation of Clinical Trials for the Treatment of Paroxysmal Atrial Fibrillation Utilizing New Convergent Ablation Procedure

nContact Surgical, Inc., a leader in the investigation of devices for minimally-invasive treatment for heart conditions, announced the initiation of a feasibility clinical trial designed to evaluate the safety and efficacy of a combined surgical and catheter procedure, the convergent procedure, for the treatment of symptomatic paroxysmal atrial fibrillation (AF). This prospective, feasibility study will enroll patients at study sites across the United States. “We designed this study to include paroxysmal patients with enlarged hearts, who historically have been more difficult to treat with catheter ablation in a single procedure,” said John P. Funkhouser, President and CEO of nContact. “The uniqueness of the convergent procedure is that lesions can be created on all areas of the heart through a closed chest endoscopic approach, without lung deflation, and while the heart is beating. It is hoped that the combination of surgical and electrophysiology techniques will enhance physicians’ capability to ultimately treat all AF patients in a single procedure.” The study utilizes the nContact Numeris® - AF Guided Coagulation System with VisiTrax® along with a commercially available ablation catheter, the Biosense Webster NaviStar® ThermoCool® Catheter. The combination of devices creates a standard, bi-atrial lesion pattern to block electrical signals that cause AF. In addition, electrophysiologists have the capability to diagnostically ensure the lesion pattern is complete with pulmonary vein isolation. “We look forward to investigating this collaborative, interdisciplinary approach for the treatment of atrial fibrillation in patients with larger atria,” said Dr. Rodney Horton, Principal Investigator at St. David’s Medical Center in Austin, Texas. nContact is a medical device company founded in 2005 with the company mission to develop devices for the endoscopic treatment of arrhythmias, including AF. The Numeris® Coagulation System with VisiTrax® is based on the unique integration of suction, perfusion, and RF energy to ensure the creation of visible, non-conductive, bi-atrial epicardial lesions on a beating heart. To date, The Numeris Coagulation System with VisiTrax is indicated for the coagulation of cardiac tissue in the United States. nContact has initiated clinical studies for the treatment of AF in both open and closed chest procedures. The Numeris Coagulation System with VisiTrax has CE Mark approval in Europe for the specific indication for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter. _________________

Stryker Announces Definitive Agreement to Acquire Ascent Healthcare Solutions

Stryker Corporation announced a definitive agreement to acquire privately held Ascent Healthcare Solutions, Inc., the market leader in the reprocessing and remanufacturing of medical devices in the U.S. Under the terms of the agreement, Stryker will acquire Ascent Healthcare Solutions for $525 million in an all cash transaction. The closing is conditioned on the expiration or termination of all applicable waiting periods pursuant to the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The board of directors of Stryker and the board of directors and shareholders of Ascent Healthcare Solutions have approved the transaction. Ascent Healthcare Solutions was formed through the 2005 merger of Vanguard Medical Concepts and Alliance Medical Corporation, two leading players in the reprocessing and remanufacturing of medical devices. With two state-of-the-art reprocessing facilities in Phoenix, Arizona and Lakeland, Florida, Ascent currently provides its services to 1,800 leading hospitals and numerous Group Purchasing Organizations throughout North America. Ascent’s market leadership position has been driven by its broad product offering, which includes cardiovascular, orthopedics, gastroenterology and general surgery devices that must comply with the U.S. Food and Drug Administration’s 510(k) and Quality System Regulation (QSR) requirements. With over 900 team members, Ascent achieved sales in 2008 in excess of $100 million. “The acquisition of Ascent Healthcare Solutions with its talented team will enhance our value proposition to hospitals and healthcare providers,” said Stephen P. MacMillan, Stryker’s Chief Executive Officer. “Conducted in accordance with FDA regulations, reprocessing and remanufacturing is one of the most impactful programs in use at hospitals, allowing for significant costs savings to the healthcare system. Additionally, Ascent’s programs allow its partner hospitals to divert thousands of pounds of medical waste from landfills while simultaneously redirecting substantial financial resources to patient care quality initiatives.” The business will become a division of Stryker operating under the MedSurg group of businesses and will continue to be known as Ascent Healthcare Solutions. The transaction, which is expected to close by year end 2009, is expected to be neutral to Stryker’s 2010 earnings per share and accretive thereafter. _______________

Europe’s Use of Device Therapy for Heart Failure Almost Doubles Between 2004-2008 — But Some Countries Still Have Very Low Rates of Uptake

The use of implantable devices for the treatment of heart failure increased “enormously” in Europe between the years 2004 and 2008, but there still remain large differences between countries, according to a study reported in the European Journal of Heart Failure,1 a journal of the Heart Failure Association of the European Society of Cardiology (ESC). The findings suggest that there is an underuse of devices in many of the 15 countries surveyed.2 The investigators note that the prognosis of heart failure — by far the single biggest reason for acute hospital admission — has not been improved by the introduction of new medical treatments in recent years, with continuing high rates of mortality and morbidity. Thus, while drug therapy is still the mainstay of treatment, “relatively few new approaches have proven beneficial,” they write. However, the use of device therapy, in particular the implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT), has gained increasing acceptance and is now being used on a large scale as an adjunct to traditional drug treatment. Indeed, some reports have described these two devices as a revolution in heart failure. One important study cited in the most recent guidelines on heart failure suggested that implantation of an ICD was associated with a 23% reduction in all-cause mortality.3 The present analysis found that throughout the 15 European countries the number of ICD implantations increased substantially, from 80/million population in 2004 to 140/million in 2008. The highest rate of ICD implants was in Germany (264/million in 2008), followed by Denmark and the Netherlands. The lowest number of implants was observed in Spain (63/million), Portugal (68/million) and the UK (74/million). The use of CRT implants also rose substantially, from 46/million in 2004 to 99/million in 2008, an increase of 115%. This increase was mainly explained by more use of devices which combine heart failure CRT and ICD therapies (CRT-D). A study reported at this year’s ESC Congress in Barcelona (MADIT-CRT) found that CRT combined with ICD decreased the risk of heart failure events even in relatively asymptomatic patients (with a 34% reduction in the risk of all-cause mortality or heart failure).4 The use of ICD (either alone or as part of a CRT-D device) has now become standard therapy for many patients with symptomatic heart failure, and is a Class I recommendation in the 2008 ESC Guidelines. The investigators thus note its relatively low use in some countries such as Spain or the UK. They cite one study suggesting “a big gap between the number of patients who fit the criteria for ICD implantation...and the number who actually get such a device.” Based on their calculation on a heart failure prevalence rate of 2-3% in the general population, the investigators estimate that around half of them would potentially have an indication for an ICD — or 10,000 per million population. However, the present data suggest that only around 250 per million population are actually receiving an ICD today — just 2.5% of those thought eligible. Noting that cost and different healthcare systems may explain some of the discrepancies in usage, the study’s first author, Professor Dirk van Veldhuisen from the University of Groningen, the Netherlands, says, “It is difficult to speculate why we see such a low rate of use in countries like Spain or UK. However, while some studies have found an added benefit from device therapy in heart failure, others have not — and we still have no clear cost-benefit analysis of their more widespread use. Certainly, implantable devices are expensive, and, if we follow the guidelines, the cost implications will be substantial.” 1 Van Veldhuisen DJ, Maass AH, Priori SG, et al. Implementation of device therapy (cardiac resynchronization therapy and implantable cardioverter defibrillator) for patients with heart failure in Europe: Changes from 2004 to 2008. Eur J Heart Fail 2009; doi:10.1093/eurjhf/hfp149. 2 Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the UK. Data is provided from each of these countries. 3 Bardy GH, Lee KL, Mark DB, et al. Amiodarone or implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225–237. 4 Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med 2009;361:1329-1338. * Heart failure is by far the single biggest reason for acute hospital admission. Around 30 million people in Europe have heart failure and its incidence is still increasing: more cases are being identified, more people are living to an old age, and more are surviving a heart attack but with damage to the heart muscle. * ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure simplify the definitions of new, transient and chronic disease. _________________

Multaq® Approved in the European Union for Patients with Atrial Fibrillation

Sanofi-aventis announced that the European Commission has granted marketing authorization for Multaq® (dronedarone - 400mg Tablets) in all 27 European member states. This approval follows the European Commission positive opinion issued on September 25, 2009 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine agency (EMEA). Multaq® is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. Multaq® discovered and developed by sanofi-aventis is the first anti-arrhythmic drug approved in the European Union that has shown a clinical benefit to reduce cardiovascular hospitalizations or death from any cause in patients with AF/AFL as described in the ATHENA trial. “The approval of Multaq® in the European Union is important news for atrial fibrillation patients who will now have access to a new treatment approach,” said Marc Cluzel, MD, Executive Vice President, Research and Development, sanofi-aventis. “The approval of Multaq® is the result of more than 15 years of research and development conducted by sanofi-aventis and supported by the commitment of the experts involved in the clinical development program and AF patients participating in the trials.” The use of dronedarone in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with left ventricular ejection fraction (LVEF) ATS Medical Announces CE Mark Approval for the ATS 3f Enable Bioprosthesis ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services announced it has received CE Mark approval to distribute the ATS 3f Enable® Aortic Bioprosthesis in the European Union, indicating it is compliant with relevant European health, safety, and environmental protection legislation. The Enable valve is the first surgical aortic valve replacement approved for commercial use that is implanted using a sutureless technique. It is the first valve of the ATS 3f Enable platform which combines the novel 3f tubular pericardial valve design with its superior hemodynamic profiles and a self-expanding frame to hold the valve in its optimal position. The goal of the Enable valve is to achieve a less invasive aortic valve replacement and reduce procedure times. Today, most aortic valve surgery cannot be done on a minimally invasive basis because precise suturing is difficult within the confined space of a minimally invasive procedure. The sutureless Enable valve can be folded into a small diameter to allow placement through a minimally invasive incision. Once the Enable valve is delivered to the site of the annulus, it is expanded to its preconfigured diameter and is held in place with a resistance fit. “We have been implanting the ATS Enable valve for four years achieving excellent hemodynamic and safety results. This valve is an important step toward the goal of reducing procedure time and allowing for a more minimally invasive approach to conventional valve surgery,” stated Professor Jerzy Sadowski, MD, PhD, Jagiellonian University, Department of CV Surgery and Transplantology, Krakow, Poland. Professor Sadowski and his surgical team performed the first human implant of the Enable valve in January 2005. “We are very excited to obtain the world’s first approval for a surgical sutureless heart valve. This initial offering in the Enable platform is an important first step in bringing disruptive technology to the traditional surgical market. Ultimately, we envision the Enable platform facilitating minimally invasive procedures for patients with conventional surgical indications,” stated Michael Dale, President and CEO of ATS Medical. “Additionally, by reducing procedural time and the trauma incurred with current conventional surgical procedures, we believe Enable may also become a viable solution for certain patients who are currently considered too sick for surgery.” Commercialization of the Enable valve will commence with a controlled market release at select surgical centers in Europe. These sites will serve as “Centers of Excellence” where surgeons throughout Europe will be trained in the state-of-the-art techniques used for implanting the Enable valve and will be instrumental in the development and launch of future generations of the ATS 3f Enable platform. Release of the second generation Enable is expected in the latter half of 2010. The company is continuing to develop sutureless tissue valve technology for use in beating heart procedures based in part on the characteristics of the next generation of Enable valves. First-in-man studies of these novel technologies are targeted for 2010. Commercialization of a beating heart solution could occur within one to two years thereafter. A valve compatible in beating heart procedures would enlarge the company’s market opportunity by providing a solution for those patients who are poor candidates to endure conventional surgery. ATS Medical, Inc. is dedicated to ‘Advancing The Standards’ of cardiac surgery through the development, manufacturing and marketing of innovative products and services for the treatment of structural heart disease. ATS Medical serves the cardiac surgery community by focusing on two distinct but operationally synergistic market segments: heart valve disease therapy and surgical ablation of cardiac arrhythmias. ATS was originally founded to develop the ATS Open Pivot® Heart Valve as a new mechanical heart valve standard of care. Today the ATS Open Pivot Heart Valve is the fastest growing mechanical prosthesis in the market. Building on this legacy and addressing the largest market segment in heart valve therapy, the ATS 3f® brand encompasses an innovative tissue heart valve portfolio to address conventional open surgery requirements as well as the growing demand for less invasive sutureless based procedures. The ATS 3f® portfolio includes offerings at various stages including early product development, pivotal clinical trials, and market commercialization. Completing the portfolio in heart valve therapy is the ATS Simulus® annuloplasty product line. Simulus products assist the surgeon in repairing a patient’s native heart valve as an alternative to replacement. Continuing ATS Medical’s focus on serving the cardiac surgery community are the ATS CryoMaze® products for surgical cryoablation of cardiac arrhythmias. ATS CryoMaze® products are used by surgeons to treat patients suffering from cardiac arrhythmias, the largest and fastest growing form of structural heart disease in populations over 60 years of age.